Pharmaceutical manufacturers said the US Food and Drug Administration (FDA) draft guidance specifying quantitative labeling recommendations for sodium, potassium and phosphorus in human over-the-counter (OTC) and prescription drugs conflicts with other existing guidelines and advice from other regulators.
The comments were made in response to the agency’s call for feedback on the draft guidance, released in September 2022, which recommends quantitative labeling of sodium, potassium and phosphates. (RELATED: FDA issues guidance documents on labeling drug identify, constituents, Regulatory Focus 13 September 2022)
In the draft guidance, FDA wrote that quantifying these constituents would help health care providers manage their patients’ total daily intake when treating conditions such as heart failure, hypertension or chronic kidney disease…
